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Description We are offering a long term contract employment opportunity for a Consultant in the Pharmaceutical industry, based in Warren, New Jersey. This role involves substantial interaction with both small and large molecule clinical and preclinical development projects, with a focus on maintaining scientific quality and adhering to regulatory guidelines.

Responsibilities:

• Execute quantitative analysis of biological samples as part of our development projects

• Develop, validate, and conduct bioanalytical assays in a regulated environment

• Uphold the scientific integrity of bioanalytical projects associated with clinical and preclinical development

• Adhere to all safety guidelines and regulatory standards in all tasks

• Contribute to the creation of analytical reports when necessary

• Ensure compliance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)

• Maintain a comprehensive and detailed laboratory notebook

• Handle additional tasks and assignments as directed by management

• Utilize laboratory equipment and techniques effectively, including ELISA and Assay Analysis

• Leverage experience in Laboratory Information Systems to streamline processes. Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

+ PhD in biology, chemistry, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline or Master’s degree in these same disciplines with a minimum of 3 years of experience or Bachelor’s degree in these same disciplines with a minimum of 5 years of experience and progressively responsible experience in regulated bioanalysis of clinical / preclinical samples (plasma, urine, cells etc.).

* Special knowledge or skills needed and/or licenses or certificates required.

+ Demonstrated experience applying analytical techniques to the regulated bioanalysis of clinical / preclinical samples (plasma, urine, cells etc.) using LC-MS/MS, quantitative PCR (qPCR), ELISA, Mesoscale Discovery (MSD) and flow cytometry techniques.

+ Applied understanding and knowledge of bioanalytical method validation guidelines governed by FDA or other global health authorities.

+ Demonstrated ability to work on complex problems to produce experimental data across one or more projects.

+ Demonstrated technical proficiency, scientific creativity, the ability to collaborate with others and the ability to think independently within a fast-paced, matrixed, team environment consisting of internal and external team members.

+ Possesses detailed and expert knowledge of scientific principles and concepts.

+ Demonstrated ability to work effectively in a multi-disciplinary team environment.

+ Proficiency with Microsoft Office. particularly MS Excel and MS PowerPoint.

+ Excellent verbal and written communication and skills.

+ Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

+ Demonstrates an understanding of the strategic alignment of his/her work with corporate goal(s) and demonstrates the ability to adapt to changing priorities and deadlines.

+ Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

+ Experience in writing analytical reports, laboratory operating procedures and work instructions.

+ Experience in working within or with a Contract Research Organization (CRO).

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